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05-09-17 FDA Opioid Workshop FDA - Training Health Care Providers on Pain Management and Safe Use of Opioid Analgesics May 9, 2017 A Matter of Record (301) 890-4188 Min-U-Script® with Word Index 1 1 FOOD AND DRUG ADMINISTRATION 2 3 4 Training Health Care Providers on 5 Pain Management and Safe Use of Opioid Analgesics 6 7 Exploring the Path Forward – An FDA Workshop 8 9 10 Tuesday, May 9, 2017 11 8:37 a.m. to 5:03 p.m. 12 13 14 15 16 Sheraton Silver Spring 17 8777 Georgia Avenue 18 Silver Spring, Maryland 19 20 21 22 A Matter of Record (301) 890-4188 2 1 C O N T E N T S 2 AGENDA ITEM PAGE 3 Opening Remarks 4 Janet Woodcock, MD 8 5 Ongoing Efforts to Address the Opioid 6 Epidemic 7 Douglas Throckmorton, MD 21 8 FDA ER/LA Opioid Analgesic REMS 9 Claudia Manzo, PharmD 31 10 Opioid Prescribing Education and Prescription 11 Drug Monitoring: A State by State Overview 12 Lisa Robin 44 13 Overview of State Efforts to Promote 14 Prevention and Education: National Governors 15 Association (NGA) Experience 16 Melissa Becker 53 17 New Mexico – A State Experience: 18 Implementation, Maintenance, and Evaluation 19 Joanna Katzman, MD, MSPH 63 20 Questions and Answers 76 21 22 A Matter of Record (301) 890-4188 3 1 C O N T E N T S (continued) 2 AGENDA ITEM PAGE 3 Provider Education and Outcomes 4 Fred Brason 94 5 Federal Healthcare System Experience: VA 6 Implementation, Maintenance, and Evaluation 7 Chester "Bernie" Good, MD 110 8 Private Healthcare System: Kaiser Permanente 9 Carol Havens, MD 121 10 Questions and Answers 137 11 Federal Mechanisms for Required Training 12 Prescriber Education: FDA REMS Options and 13 Considerations 14 Doris Auth, PharmD 149 15 DEA Perspective 16 James Arnold 168 17 Open Public Hearing 18 Norman Kahn, MD 180 19 Thomas Sullivan 183 20 Cynthia Kear 189 21 Eunan Maguire 192 22 Katherine Cates-Wessel 195 A Matter of Record (301) 890-4188 4 1 C O N T E N T S (continued) 2 AGENDA ITEM PAGE 3 Open Public Hearing (continued) 4 Richard Lawhern 200 5 Laura Wooster 204 6 Clif Knight, MD 206 7 Ilana Hardesty 210 8 Steven Passik, PhD 213 9 Ashley Walton 217 10 Linda Cheek 220 11 Kara Gainer 223 12 Panel Discussion – Professional Associations 13 Terry Toigo, MBA, RPh 226 14 Questions and Answers 15 State Panel Discussion 16 Peter Lurie, MD, MPH 299 17 David Brown 300 18 Questions and Answers 353 19 Closing Remarks 20 Douglas Throckmorton, MD 370 21 22 A Matter of Record (301) 890-4188 5 1 P R O C E E D I N G S 2 (8:37 a.m.) 3 DR. THROCKMORTON: Good morning, everybody. 4 If you could sit down we'll go ahead and get 5 started. Today, we have a busy two-day meeting 6 here. 7 My name is Doug Throckmorton. I am the 8 deputy center director at the Center for Drugs, and 9 I've met many of you at some of the other meetings 10 we've had related to the opioids epidemic in the 11 past. Welcome to you again today. 12 Very busy, very important two-day meeting 13 here to talk about the place that education has, 14 especially the place that federal education has in 15 addressing the opioids crisis that I know that we 16 are all very familiar with and all committed to 17 doing something to address that that's meaningful, 18 that makes a real difference. 19 The two days here are particularly exciting 20 for me because of the broad range of groups that we 21 have here. Mary tells me that there are 25 22 organizations at the state federal level, consumer A Matter of Record (301) 890-4188 6 1 advocacy groups, and from state and local, medical 2 boards, pharmacy boards, and the like, all 3 scheduled to talk at one part of the meeting or the 4 other in the next couple of days. In addition, 5 from the federal space, we have representatives 6 from almost the entire range of agencies that are 7 working in this area CDC, CMS, SAMHSA, NIDA, FDA 8 obviously. I'm probably missing -- oh, DEA is 9 going to be coming as well. 10 So a really broad range of voices, something 11 that is really important for us as an agency, as we 12 decide where to go next in this area of federal 13 education. And then, decide how to do it as best 14 we can, to do the most effective job at educating 15 and training healthcare professionals in this 16 terribly important area. 17 Our intent is to listen closely and to take 18 the things that you all say seriously. I am going 19 to be planning on summarizing what we've heard at 20 the end of the second day. I hope we're going to 21 have a vigorous discussion, one that we will be 22 able to make important use of. A Matter of Record (301) 890-4188 7 1 Before I turn the podium over to 2 Dr. Woodcock, I have some housekeeping things I 3 have been asked to remind people of. One, please 4 turn off or silence your phones. There is a one- 5 hour lunch break. The restrooms are down the hall 6 and to the right, important things like that. 7 The open public hearings are scheduled each 8 day. If you are interested in speaking, go to the 9 registration table. That's right outside and let 10 them know, and we will make time for you. 11 There is a docket that has been set up for 12 this. That docket will remain open until July 13 10th. As you'll hear, we are hoping that docket is 14 going to be useful for you for giving us some 15 additional information, things that we should take 16 into consideration. 17 A transcript of the meeting will be posted 18 within 30 days of the meeting. A webcast is being 19 done, and that will be archived for later viewing. 20 Because there is a webcast, if you make comments, 21 please make them into a microphone so they can be 22 captured and available for people listening on the A Matter of Record (301) 890-4188 8 1 Web. And then finally, again, thank you very much 2 for participating in this. We are taking this very 3 seriously, and appreciate all of your time and 4 attention to this matter. 5 With that, I am going to turn the podium 6 over to Dr. Woodcock, who is the head of the Center 7 for Drug Evaluation and Research to give us some 8 opening remarks. 9 Janet? 10 Opening Remarks – Janet Woodcock 11 DR. WOODCOCK: Thanks Doug, and good 12 morning, everyone. I am very happy to be here and 13 kick this meeting off. To start, I would really 14 like to step back a little bit and say where we 15 are, we have come from, how did we get to this 16 place. 17 Well, right now, as everyone in this room 18 knows very well, there is an epidemic of use of 19 prescription opioids and related substance abuse. 20 And FDA has been executing an action plan that we 21 published a year ago on a large number of steps we 22 are trying to take to help control this. A Matter of Record (301) 890-4188 9 1 I think everyone agrees that this can't be 2 done by one entity alone. That's why there's so 3 many different groups represented here. It is 4 going to take concerted effort at the federal, 5 state, local, professional society level to manage 6 this. 7 But FDA's part of the plan, we try to 8 decrease exposure, overall exposure to prescription 9 opioids. We've been approving alternative pain 10 medications, so that there are other tools that 11 prescribers have when someone presents with pain. 12 We've been stressing education under our 13 REMS program and offering educational programs for 14 several years, and that's been very successful. A 15 large number of healthcare professionals have taken 16 CME programs, educational programs, under this. 17 We also have been trying to decrease the 18 non-medical use of opioids by approving 19 abuse-deterrent formulations of various types, and 20 that is an experiment that we still are assessing 21 how effective various abuse-deterrent formulations 22 might be. We view that we have version 1.0, maybe A Matter of Record (301) 890-4188 10 1 1.2 of abuse-deterrent formulation. We hope we get 2 up to a very effective abuse-deterrent 3 formulations, but of course any formulation can be 4 overcome; this is not the entire answer. 5 We're also trying to decrease non-medical 6 use by encouraging disposal and take-back 7 practices, so that there are not so many 8 prescription bottles available, not being used. 9 We are trying to decrease overdosing deaths 10 and use of naloxone in various forms as an antidote 11 to the respiratory depression caused by opioids, 12 and we would like to see more treatment options for 13 people who have opioid substance-use disorder. 14 That is a field that probably can be explored much 15 more and a great opportunity to treat those who 16 already have issues.
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